Treadmill Training With Lower Extremity Amputees

Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.

Study Overview

• Status: Completed
• Conditions: Traumatic Amputation of Lower Extremity
• Intervention / Treatment: Other: Treadmill Training

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Leg amputation that is either below the knee, through the knee, or above the knee
• Ability to walk with prosthetic
• Comfortably fitted with a prosthesis for at least 6 months
• Not currently receiving physical therapy for gait training
• Able to tolerate a moderate intensity exercise program

Exclusion Criteria:

• People with severe cardiac or pulmonary disease that limits ability to exercise.
• People with too much discomfort and/or pain that restricts their ability to walk.
• People with active wounds on their residual limb or contralateral foot.
• People who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: No Body weight support	Other: Treadmill Training; The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.
EXPERIMENTAL: Body weight support	Other: Treadmill Training; The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in 6-minute walk test	Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol	Baseline, after training, 1 month follow-up

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Eric Lamberg, EdD, PT, Stony Brook University

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (ESTIMATE): August 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Amputees
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 2009-0573-1